Novartis' Sandoz resubmits FDA application for pegfilgrastim

Novartis announced on Wednesday that its biosimilars division Sandoz had resubmitted its biologics license application (BLA) for a proposed biosimilar ‘pegfilgrastim’ to the US Food and Drug Administration (FDA), to address an FDA complete response letter received in June 2016.

The Swiss pharmaceuticals giant described pegfilgrastim as a long-acting version of filgrastim, which could be prescribed to appropriate cancer patients undergoing chemotherapy to enhance the production of infection-fighting white blood cells.

It said studies had shown that each year in the US, 4,000 cancer patients died of febrile neutropenia, and 60,000 were hospitalized due to neutropenia.

Biosimilars could help create the potential to save the US healthcare system up to $54bn over 10 years, Novartis claimed, adding that access to more treatment options for neutropenia was “urgently” needed, as cancer-related neutropenia hospitalizations could amount to as much as $2.3bn in costs per year.

“For the tens of thousands of US cancer patients undergoing chemotherapy, treatment options that can be individualised right from the start, such as long- and short-acting filgrastim biosimilars, are key to help manage the risk of serious complications related to infection," said Sandoz managing director, global head of development, biopharmaceuticals Mark Levick.

“The US market is just beginning to benefit from biosimilars, as shown by the success of our filgrastim, the first approved biosimilar in the US.

“The submission of our pegfilgrastim biosimilar application is another step for us as we continue to lead the way in creating early and expanded patient access to life-changing biologics.”

Sandoz said the biosimilar pegfilgrastim was designed to match the reference medicine, explaining that it was pursuing its approval to decrease the incidence of infection, as manifested by febrile neutropenia - low white blood cell count with a fever - in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

The company said the resubmission included new data from a pivotal pharmacokinetics (PK) and pharmacodynamics (PD) study.

That was a single-dose, three-period cross-over study comparing Sandoz pegfilgrastim with US-sourced reference pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US with EU-sourced reference pegfilgrastim.